I. GMP Guideline for Drug Products: Text - NIHS

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添付資料 4 GMP Guideline for Drug Products8.60 As to drug products whose sterility is not required, appropriate written proceduresshould be established and complied with to prevent undesirable microbiologicalcontamination.32
添付資料 4 GMP Guideline for Drug Products9 Packaging and Labeling9.1 General9.10 Control of packaging and labeling materials should be conducted as defined in thischapter, in addition to the control defined in Chapter 7 (Control of Raw Materialsand Packaging/Labeling Materials). This chapter applies to the packaging andlabeling materials that are used for the drug products and intermediate products tobe released to other manufacturers. This chapter does not apply to the in-processproducts that are tentatively stored at the site of manufacturer.9.2 Control of Packaging Materials9.20 If necessary considering product characteristics, packaging materials should becleaned and sterilized before use so as to assure the compliance with the intendeduse. Packaging materials should be appropriately controlled to maintain thecleanliness where applicable.9.3 Control of Labeling Materials9.30 Labeling materials should be stored in the storage area where only authorizedpersonnel can access, or stored by the method that allows equivalent or higherlevels of control.9.31 Contents to be labeled should include the product name, lot number, quantity,expiry date, and storage condition where applicable. For drug products to whichexpiry dates are not applied, description of expiry dates is not required on labels.9.32 Numbers of labeling materials issued, used, and returned should be confirmed. Incase of discrepancies found between the number of containers/packages with thelabeling materials applied and the number of issued labeling materials, the causesof the discrepancies should be investigated, and the results should be reported toand approved by the quality unit.9.33 All excess labeling materials bearing lot numbers or other lot-related informationshould be destroyed. As to excess labeling materials that bear neither lot numbersnor other lot-related information and that are returned to be reused, mix-up shouldbe prevented, and appropriate methods for storage should be taken to ascertainabsence of mix-up.9.34 Obsolete and/or out-dated labeling materials should be destroyed.9.35 Printing devices used to print labeling items on labeling materials and those used toprint lot numbers on packaging materials should be controlled so that all itemsdefined in the manufacturing instructions should be printed.9.36 Labeling materials issued for specific lots should be examined for conformity tospecifications defined in the manufacturing instructions and for appropriate33
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